BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 3892927 · Received June 24, 2014

    Report

    Report Number
    1416980-2014-20201
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Report Date
    May 30, 2014
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE WAS DISCARDED BY THE USER; HOWEVER, AN UNUSED DEVICE OF THE SAME LOT WAS RECEIVED AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE COMPANION SAMPLE FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED WITH NO DEFECTS NOTED. THE VACUUM OF THE SAMPLE WAS MEASURED AND WAS WITHIN SPECIFICATION. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 1000 ML EVACUATED CONTAINER LOST ITS VACUUM PRESSURE. THIS OCCURRED WHILE THE DEVICE WAS CONNECTED TO TUBING WITH AN 18 GAUGE NEEDLE AND WHILE FLUID WAS BEING DRAINED FROM THE PATIENT¿S ABDOMEN. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368628 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - CLEVELAND G111351

    Patients

    Seq Age Sex Outcome Treatment
    1